To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period

• ClinicalTrials.gov Identifier: NCT05324293
• Recruitment Status: Completed
• First Posted: April 12, 2022
• Last Update Posted: November 15, 2023
• Sponsor: Hope Medicine (Nanjing) Co., Ltd
• Information provided by (Responsible Party): Hope Medicine (Nanjing) Co., Ltd

Tracking Information

• First Submitted Date: March 30, 2022
• First Posted Date: April 12, 2022
• Last Update Posted Date: November 15, 2023
• Actual Study Start Date: May 11, 2022
• Actual Primary Completion Date: September 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2022)

TAHC(target area hair count) of non-vellus [ Time Frame: From baseline to Week 24 ]

Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 11, 2022)

• TAHC of non-vellus [ Time Frame: From baseline to Week 6, 12, 18, and 36 ]
  Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.
• TAHW(target area hair width) of non-vellus hair [ Time Frame: From baseline to Week 6, 12, 18, 24, and 36 ]
  Change in target area hair width (TAHW) of non-vellus hair from baseline to Week 6, 12, 18, 24, and 36 in male and female, respectively.
• Investigator Global Assessment (IGA) [ Time Frame: Week 6, 12, 18, 24, and 36 ]
  IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
• Subject self-Assessment (SSA) [ Time Frame: Week 6, 12, 18, 24, and 36 ]
  SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
• Hair growth questionnaire assessment (HGQA) [ Time Frame: Week 6, 12, 18, 24, and 36 ]
  HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period
• Official Title: An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female With Androgenetic Alopecia Treated With HMI-115 Over a 24-Week Treatment Period
• Brief Summary: An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Androgenetic Alopecia

Intervention

Drug: HMI-115

Once Every 2 weeks, subcutaneously injection

Study Arms

Experimental: HMI-115 240mg

Intervention: Drug: HMI-115

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 16, 2023): 16
• Original Estimated Enrollment (submitted: April 11, 2022): 20
• Actual Study Completion Date: September 11, 2023
• Actual Primary Completion Date: September 11, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.

Exclusion Criteria:

1. Subject with clinical diagnosis of non-AGA
2. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
3. Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
4. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
5. Subject has clinically significantly abnormal laboratory tests at Screening
6. Known hypersensitivity to any of the IMP ingredients
7. Any other conditions in the investigator's opinion that prevent the subject from participating

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT05324293
• Other Study ID Numbers: HMI-115102
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hope Medicine (Nanjing) Co., Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Hope Medicine (Nanjing) Co., Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hope Medicine (Nanjing) Co., Ltd
• Verification Date: October 2023